Generalized Myasthenia GravisNCT06967480
Early Ravulizumab Treatment Of Anti- AChR Antibody-Positive Generalized Myasthenia Gravis
An observational study of Generalized Myasthenia Gravis and Anti-AChR Antibody Positive, run by Alexion Pharmaceuticals, Inc. at 23 sites in Italy.
Trial summary
The primary objective of the study is to evaluate the effectiveness of Ravulizumab in improving MG-ADL in an early-stage AChR+ gMG population. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Generalized Myasthenia Gravis, Anti-AChR Antibody Positive
- What is being tested?
- Ravulizumab
- How many people
- 40 participants
- Where
- 23 sitesItaly
- Study dates
- 31 Jul 2025to 30 Jun 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with anti-AChR antibody positive, generalized, myasthenia gravis elegible to Ravulizumab treatment with a disease duration from onset equal or less than 3 years.
Who may be able to join
- Diagnosis of MG confirmed by:
- History of a positive serologic test for anti-AChR antibodies, and
- One of the following:
- History of abnormal neuromuscular transmission test demonstrated by singlefibre electromyography or repetitive nerve stimulation
- History of positive anticholinesterase test (e.g., edrophonium chloride test); or
- Patient demonstrated improvement in MG signs on oral cholinesterase inhibitors, as assessed by the treating physician
Show all 10Show fewer
- Disease duration from MG onset ≤ 3 years before T-4 (Enrolment);
- MGFA class IIb to IV;
- Patient eligible for Ravulizumab treatment based on AIFA reimbursement criteria
- Vaccination cycle for Neisseria meningitidis completed at least two weeks before Ravulizumab initiation or antibiotics chemoprophylaxis according to the SmPC.
Who cannot join
- Patient unable to understand and sign the informed consent
- Hypersensitivity to the active substance or to any of the excipients of the study product
- Patient for whom the study product is contraindicated according to SmPC
- Previous treatment with C5 inhibitors
- Last rituximab infusion performed < 6 months before T-4 (Enrolment)
- Last infusion with FcRn blockers performed < 3 months before T-4 (Enrollment)
Show all 11Show fewer
- Pregnant or lactating or planning a pregnancy during the study
- Patient who plan to relocate during the study
- Patient who are unsure of following the visit schedule
- Patient unable to complete questionnaires
- Previous or current participation to other interventional studies
Trial locations and contacts
23 sites in 1 country. Contact the study team or a site near you to ask about taking part.
23 sites in 1 country
Italy23 sites, 23 recruiting
- Recruiting
Clinical Trial Site
Bergamo
- Not yet recruiting
Clinical Trial Site
Bologna
- Recruiting
Clinical Trial Site
Bologna
- Recruiting
Clinical Trial Site
Brescia
- Recruiting
Clinical Trial Site
Florence
- Not yet recruiting
Clinical Trial Site
Imperia
- Recruiting
Clinical Trial Site
Lecco
- Not yet recruiting
Clinical Trial Site
Messina
- Recruiting
Clinical Trial Site
Milan
- Not yet recruiting
Clinical Trial Site
Milan
- Not yet recruiting
Clinical Trial Site
Naples
- Not yet recruiting
Clinical Trial Site
Novara
- Not yet recruiting
Clinical Trial Site
Orbassano
- Not yet recruiting
Clinical Trial Site
Padova
- Not yet recruiting
Clinical Trial Site
Palermo
- Recruiting
Clinical Trial Site
Parma
- Not yet recruiting
Clinical Trial Site
Pavia
- Not yet recruiting
Clinical Trial Site
Pisa
- Not yet recruiting
Clinical Trial Site
Roma
- Not yet recruiting
Clinical Trial Site
Salerno
- Recruiting
Clinical Trial Site
San Giovanni Rotondo, 71013
- Recruiting
Clinical Trial Site
Sassari
- Not yet recruiting
Clinical Trial Site
Torino
About this study
Official title: MG-EVOLUTION. Early Ravulizumab Treatment Of Anti- AChR Antibody-Positive Generalized Myasthenia Gravis: A Real-World Study With Biomarker Analysis
The primary objective of the study is to evaluate the effectiveness of Ravulizumab in improving MG-ADL in an early-stage AChR+ gMG population.
- Being tested
- Ravulizumab
- Keywords
- Anti-AChR Antibody-Positive, Generalized Myasthenia Gravis, gMG, Ravulizumab
- Medical subject headings
- Myasthenia Gravis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RavulizumabDrug
Participants will receive Ravulizumab.
| Study group | Role | What they receive |
|---|---|---|
| Ravulizumab | Participants will receive Ravulizumab until Week 50 ± 14 days after baseline or until discontinuation. Receives: Drug: Ravulizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Myasthenia Gravis-Activities of Daily Living (MG-ADL) Total Score at Week 50
Measured: Week 50
Change From Baseline in MG-ADL Total Score at Week 50
Measured: Baseline, Week 50
Secondary outcomes (24)
MG-ADL Total Score at Weeks 2, 10, and 26
Measured: Weeks 2, 10, and 26
Change From Baseline in MG-ADL Total Score at Weeks 2, 10 and 26
Measured: Baseline, Weeks 2, 10 and 26
Percentage of Participants With >=2- Point Reduction From Baseline in MG-ADL Total Score at Weeks 2, 10, 26, and 50
Measured: Baseline, Weeks 2, 10, 26, and 50
Quantitative Myasthenia Gravis (QMG) Total Score at Weeks 2, 10, 26, and 50
Measured: Weeks 2, 10, 26, and 50
Change From Baseline in QMG Total Score at Weeks 2, 10, 26 and 50
Measured: Baseline, Weeks 2, 10, 26 and 50
Percentage of Participants With >=3- Point Reduction From Baseline in QMG Total Score at Weeks 2, 10, 26, and 50
Measured: Baseline, Weeks 2, 10, 26, and 50
Myasthenia Gravis Composite (MGC) Total Score at Weeks 2, 10, 26, and 50
Measured: Weeks 2, 10, 26, and 50
Change From Baseline in MGC Total Score at Weeks 2,10, 26 and 50
Measured: Baseline, Weeks 2, 10, 26 and 50
Percentage of Participants With >=3- Point Reduction From Baseline in MGC Total Score at Weeks 2, 10, 26 and 50
Measured: Baseline, Weeks 2, 10, 26, and 50
Myasthenia Gravis Quality of Life 15-Item Scale - Revised (MG-QoL15r) Total Score at Weeks 10, 26, and 50
Measured: Weeks 10, 26, and 50
Change From Baseline in MG-QoL15r Total Score at Weeks 10, 26 and 50
Measured: Baseline, Weeks 10, 26 and 50
Hospital Anxiety and Depression Scale (HADS) Total Score at Weeks 10, 26, and 50
Measured: Weeks 10, 26, and 50
Change From Baseline in HADS Total Score at Weeks 10, 26 and 50
Measured: Baseline, Weeks 10, 26 and 50
Insomnia Severity Index Scale (ISI) Total Score at Weeks 10, 26, and 50
Measured: Weeks 10, 26, and 50
Change From Baseline in ISI Total Score at Weeks 10, 26 and 50
Measured: Baseline, Weeks 10, 26 and 50
Pain Visual Analogue Scale (Pain VAS) Total Score at Weeks 2, 10, 26, and 50
Measured: Weeks 2, 10, 26, and 50
Change From Baseline in Pain VAS Total Score at Weeks 2, 10, 26 and 50
Measured: Baseline, Weeks 2, 10, 26 and 50
Percentage of Participants With Mean Dose Reduction From Baseline of Corticosteroids and Immunosuppressants (ISTs) Treatment at Weeks 2, 10, 26, and 50
Measured: Baseline, Weeks 2, 10, 26, and 50
Percentage of Participants in Different ISTs Status at Baseline, and at Weeks 2, 10, 26, and 50
Measured: Baseline, Weeks 2, 10, 26, and 50
Number of Clinical Deterioration Events
Measured: Baseline, Weeks 2, 10, 26, and 50
Percentage of Participants With Minimal Symptom Expression at Weeks 2, 10, 26, and 50
Measured: Weeks 2, 10, 26, and 50
Institute For Medical Technology Assessment (iMTA) Productivity Cost Questionnaire (iPCQ) Score at Weeks 10, 26, and 50
Measured: Weeks 10, 26, and 50
Change From Baseline in iMTA iPCQ Score at Weeks 10, 26 and 50
Measured: Baseline, Weeks 10, 26 and 50
Biomarkers analyses (complement system proteins, interleukins and miRNA serum levels)
Measured: Baseline, Week 10, 26, and 50
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2025
- Study start31 Jul 2025
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Generalized Myasthenia GravisStudies of the same condition, open and under way.
- More trials run by Alexion Pharmaceuticals, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alexion Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06967480
- Sponsor's protocol ID
- D9281R00002
- Status last verified
- Feb 2026
- First submitted
- 5 May 2025
- Last updated
- 5 Feb 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Alexion has a public commitment to allow requests for access to study data and will be supplying a protocol, CSR, and plain language summaries.
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MG-EVOLUTION. Early Ravulizumab Treatment Of Anti- AChR Antibody-Positive Generalized Myasthenia Gravis: A Real-World Study With Biomarker Analysis
- ClinicalTrials.gov ID
- NCT06967480
- Acronym / sponsor ID
- D9281R00002
- Keywords
- Anti-AChR Antibody-Positive, Generalized Myasthenia Gravis, gMG, Ravulizumab
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Alexion Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- 31 Jul 2025 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 13 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of the study is to evaluate the effectiveness of Ravulizumab in improving MG-ADL in an early-stage AChR+ gMG population.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ravulizumab | – | Drug: RavulizumabParticipants will receive Ravulizumab until Week 50 ± 14 days after baseline or until discontinuation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with anti-AChR antibody positive, generalized, myasthenia gravis elegible to Ravulizumab treatment with a disease duration from onset equal or less than 3 years.
Key inclusion criteria (10 listed)
- Diagnosis of MG confirmed by:
- Disease duration from MG onset ≤ 3 years before T-4 (Enrolment);
- MGFA class IIb to IV;
- Patient eligible for Ravulizumab treatment based on AIFA reimbursement criteria
- Vaccination cycle for Neisseria meningitidis completed at least two weeks before Ravulizumab initiation or antibiotics chemoprophylaxis according to the SmPC.
Key exclusion criteria (11 listed)
- Patient unable to understand and sign the informed consent
- Hypersensitivity to the active substance or to any of the excipients of the study product
- Patient for whom the study product is contraindicated according to SmPC
- Previous treatment with C5 inhibitors
- Last rituximab infusion performed < 6 months before T-4 (Enrolment)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RavulizumabParticipants will receive Ravulizumab. | Drug | Ravulizumab |
Primary outcome
Myasthenia Gravis-Activities of Daily Living (MG-ADL) Total Score at Week 50
Time frame: Week 50
Change From Baseline in MG-ADL Total Score at Week 50
Time frame: Baseline, Week 50
24 secondary outcomes
MG-ADL Total Score at Weeks 2, 10, and 26
Time frame: Weeks 2, 10, and 26
Change From Baseline in MG-ADL Total Score at Weeks 2, 10 and 26
Time frame: Baseline, Weeks 2, 10 and 26
Percentage of Participants With >=2- Point Reduction From Baseline in MG-ADL Total Score at Weeks 2, 10, 26, and 50
Time frame: Baseline, Weeks 2, 10, 26, and 50
Quantitative Myasthenia Gravis (QMG) Total Score at Weeks 2, 10, 26, and 50
Time frame: Weeks 2, 10, 26, and 50
Change From Baseline in QMG Total Score at Weeks 2, 10, 26 and 50
Time frame: Baseline, Weeks 2, 10, 26 and 50
Percentage of Participants With >=3- Point Reduction From Baseline in QMG Total Score at Weeks 2, 10, 26, and 50
Time frame: Baseline, Weeks 2, 10, 26, and 50
Myasthenia Gravis Composite (MGC) Total Score at Weeks 2, 10, 26, and 50
Time frame: Weeks 2, 10, 26, and 50
Change From Baseline in MGC Total Score at Weeks 2,10, 26 and 50
Time frame: Baseline, Weeks 2, 10, 26 and 50
Percentage of Participants With >=3- Point Reduction From Baseline in MGC Total Score at Weeks 2, 10, 26 and 50
Time frame: Baseline, Weeks 2, 10, 26, and 50
Myasthenia Gravis Quality of Life 15-Item Scale - Revised (MG-QoL15r) Total Score at Weeks 10, 26, and 50
Time frame: Weeks 10, 26, and 50
Change From Baseline in MG-QoL15r Total Score at Weeks 10, 26 and 50
Time frame: Baseline, Weeks 10, 26 and 50
Hospital Anxiety and Depression Scale (HADS) Total Score at Weeks 10, 26, and 50
Time frame: Weeks 10, 26, and 50
Change From Baseline in HADS Total Score at Weeks 10, 26 and 50
Time frame: Baseline, Weeks 10, 26 and 50
Insomnia Severity Index Scale (ISI) Total Score at Weeks 10, 26, and 50
Time frame: Weeks 10, 26, and 50
Change From Baseline in ISI Total Score at Weeks 10, 26 and 50
Time frame: Baseline, Weeks 10, 26 and 50
Pain Visual Analogue Scale (Pain VAS) Total Score at Weeks 2, 10, 26, and 50
Time frame: Weeks 2, 10, 26, and 50
Change From Baseline in Pain VAS Total Score at Weeks 2, 10, 26 and 50
Time frame: Baseline, Weeks 2, 10, 26 and 50
Percentage of Participants With Mean Dose Reduction From Baseline of Corticosteroids and Immunosuppressants (ISTs) Treatment at Weeks 2, 10, 26, and 50
Time frame: Baseline, Weeks 2, 10, 26, and 50
Percentage of Participants in Different ISTs Status at Baseline, and at Weeks 2, 10, 26, and 50
Time frame: Baseline, Weeks 2, 10, 26, and 50
Number of Clinical Deterioration Events
Time frame: Baseline, Weeks 2, 10, 26, and 50
Percentage of Participants With Minimal Symptom Expression at Weeks 2, 10, 26, and 50
Time frame: Weeks 2, 10, 26, and 50
Institute For Medical Technology Assessment (iMTA) Productivity Cost Questionnaire (iPCQ) Score at Weeks 10, 26, and 50
Time frame: Weeks 10, 26, and 50
Change From Baseline in iMTA iPCQ Score at Weeks 10, 26 and 50
Time frame: Baseline, Weeks 10, 26 and 50
Biomarkers analyses (complement system proteins, interleukins and miRNA serum levels)
Time frame: Baseline, Week 10, 26, and 50
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2026.
- Individual participant dataSharing planned: Yes. Alexion has a public commitment to allow requests for access to study data and will be supplying a protocol, CSR, and plain language summaries.
Related trials for Generalized Myasthenia Gravis
Active, not recruitingPhase 3
An Extension Study Evaluating 6-week Treatment Cycles of Rozanolixizumab in Pediatric Study Participants With Generalized Myasthenia Gravis
Generalized Myasthenia Gravis
Recruiting
Holistic Assessment and Remote Digital MONitoring of mYasthenia Gravis Via MyoSense 360
Myasthenia Gravis, Generalized
RecruitingPhase 3
A Study of Nipocalimab Administered to Adults With Generalized Myasthenia Gravis
Myasthenia Gravis
RecruitingPhase 2/3
A Study to Evaluate Subcutaneous Zilucoplan in Pediatric Participants With Generalized Myasthenia Gravis
Generalized Myasthenia Gravis
Not yet recruitingEarly Phase 1
A Clinical Study to Evaluate the Safety and Efficacy of GT802 Injection in the Treatment of Refractory Generalized Myasthenia Gravis
Generalized Myasthenia Gravis (gMG)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
23 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Generalized Myasthenia Gravis and Anti-AChR Antibody Positive, run by Alexion Pharmaceuticals, Inc. at 23 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alexion Pharmaceuticals, Inc. (Sponsor) (1-855-752-2356, clinicaltrials@alexion.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Myasthenia Gravis-Activities of Daily Living (MG-ADL) Total Score at Week 50 (time frame: Week 50). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2026.